CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Composition:

CYCLOBENZAPRINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclobenzaprine hydrochloride tablets, USP is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate  evidence of effectiveness for more prolonged use is not available and because muscle spasm associated  with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO) in

Product summary:

Cyclobenzaprine hydrochloride tablets, USP are available in 5 mg and 10 mg dosage strength. The 5 mg tablets are supplied as orange film coated round shaped biconvex tablets debossed “K 6” on one side and plain on other side. Bottles of 10 - 68788-9508-0 Bottles of 14 - 68788-9508-1 Bottles of 15 - 68788-9508-5 Bottle of 20 - 68788-9508-2 Bottle of 30 - 68788-9508-3 Bottle of 60 - 68788-9508-6 Bottle of 90 - 68788-9508-9 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature]. Dispense in a tight, well-closed, container as defined in the USP, with a child-resistant closure (as required). Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940-1850 Item ID # 006013/06   12/14 Manufacturer’s Code: 10702 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
DESCRIPTION
Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine
salt with the empirical formula
C
H N• HCl and a molecular weight of 311.9. It has a melting point of
217°C and a pKa of 8.47 at
25°C. It is freely soluble in water and alcohol, sparingly soluble in
isopropanol, and insoluble in
hydrocarbon solvents. If aqueous solutions are made alkaline, the free
base separates.
Cyclobenzaprine hydrochloride is designated chemically as
3-(5H-dibenzo [a,d] cyclohepten-5-
ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the
following structural formula:
Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration
contains 5 mg Cyclobenzaprine
hydrochloride.
Each 10 mg Cyclobenzaprine hydrochloride tablet for oral
administration contains 10 mg
Cyclobenzaprine hydrochloride.
Each tablet contains the following inactive ingredients: lactose
monohydrate, microcrystalline
cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate,
carnauba wax, titanium dioxide,
polyethylene glycol, and iron oxide yellow.
In addition, 5 mg tablets also contain polyvinyl alcohol, talc,
lecithin, and FD&C yellow # 6 / sunset
yellow FCF aluminum lake.
In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake,
FD&C yellow # 6 aluminum
lake and hypromellose.
CLINICAL PHARMACOLOGY
Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local
origin without interfering with
muscle function. It is ineffective in muscle spasm due to central
nervous system disease.
Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in
several animal models. Animal
studies indicate that cyclobenzaprine does not act at the
neuromuscular junction or directly on skeletal
muscle. Such studies show that cyclobenzaprine acts primarily within
the central nervous system at brain
stem as opposed to spinal cord levels, althou